Comparative evaluation of a dual-target real-time RT-PCR assay for COVID-19 diagnosis and assessment of performance in pooled saliva and nasopharyngeal swab samples
| العنوان: | Comparative evaluation of a dual-target real-time RT-PCR assay for COVID-19 diagnosis and assessment of performance in pooled saliva and nasopharyngeal swab samples |
|---|---|
| المؤلفون: | Kit-Hang Leung, Jasper Fuk-Woo Chan, Ivan Hung, Kelvin K. W. To, Kwok-Hung Chan, Siddharth Sridhar, Cyril C. Y. Yip, Vincent C.C. Cheng, Anthony Chin-Ki Ng |
| المصدر: | Expert Review of Molecular Diagnostics article-version (VoR) Version of Record |
| بيانات النشر: | Taylor & Francis, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | 0301 basic medicine, Dual target, Saliva, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), real-time RT-PCR, Real-Time Polymerase Chain Reaction, Pathology and Forensic Medicine, Comparative evaluation, Specimen Handling, 03 medical and health sciences, 0302 clinical medicine, Genetics, Proficiency testing, medicine, Humans, pooling, Molecular Biology, Original Research, medicine.diagnostic_test, business.industry, SARS-CoV-2, Reverse Transcriptase Polymerase Chain Reaction, diagnostic test evaluation, Nucleic acid test, COVID-19, Molecular biology, 030104 developmental biology, Real-time polymerase chain reaction, 030220 oncology & carcinogenesis, COVID-19 Nucleic Acid Testing, Molecular Medicine, RNA, Viral, business, Research Article |
| الوصف: | Objectives: Sensitive molecular diagnostic assays are essential for COVID-19 diagnosis. We evaluated the Hecin Scientific SARS-CoV-2 nucleic acid test kit, a dual-target real-time RT-PCR assay targeting the SARS-CoV-2 N and ORF1ab genes. Methods: The Hecin test kit’s diagnostic performance in detecting SARS-CoV-2 RNA was compared to the LightMix Modular SARS and Wuhan CoV E-gene kit (TIB Molbiol) and an in-house single-tube nested real-time RT-PCR using 296 clinical specimens, 11 proficiency testing samples, and 30 low-positive deep throat saliva and nasopharyngeal swab (NPS) samples pooled into negative samples in ratios of 1:5, 1:10, and 1:30. Results: The limit-of-detection of the Hecin test kit was around 500 dC/mL for the N and ORF1ab targets. Sensitivity and specificity of the Hecin test kit were 98.1% (95% CI: 93.4–99.8%) and 100% (98.1–100%), respectively, when measured against the reference method. The Hecin test kit showed fair sensitivity (80%) in low-positive NPS samples pooled in ratios of 1:5 and 1:10. Its performance in pooled samples could be dramatically improved by adjusting the assay Ct cutoff. Conclusion: The Hecin test kit enables sensitive and specific detection of SARS-CoV-2 in clinical samples and pooled samples. |
| اللغة: | English |
| تدمد: | 1744-8352 1473-7159 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e637c570ce55d8315e1bdf6fab83435cTest http://europepmc.org/articles/PMC8182820Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....e637c570ce55d8315e1bdf6fab83435c |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 17448352 14737159 |
|---|